The Harmonization of the Microbial Limits Test

Absence of Specified Organisms

Scott Sutton, Ph.D.
http://www.linkedin.com/in/scottvwsutton
This article first appeared in the PMF Newsletter of January, 2006 and is
protected by copyright to PMF. It appears here with permission.

The last issue of the PMF Newsletter (vol 12, no. 3) contained a review of
the harmonization status of the Microbial Limits Tests Enumeration. In
addition, the article provided a brief overview of the compendial
harmonization process as agreed to by the Pharmacopeial Discussion
Group (PDG). In this article, I would like to focus on the other side of the
Microbial Limits Tests the Absence of Specified Microorganisms
component.

Table 1: Harmonized Chapter Numbering Scheme

USP EP

<61> Microbiological Examination Of 2.6.12 Microbiological Examination Of

Nonsterile Products: Microbial Enumeration Nonsterile Products: Microbial Enumeration
Tests Tests

<62> Microbiological Examination of 2.6.13 Microbiological Examination of

Nonsterile Products: Tests for Specified Nonsterile Products: Tests for Specified
Microorganisms Microorganisms

<1111> Microbiological Quality of Nonsterile 5.1.4 Microbiological Quality of Nonsterile

Pharmaceutical Products Pharmaceutical Products

There is a significant controversy in the United States over the intent of this
evaluation. The FDA is bound by the concern expressed in the Code of
Federal Regulations (21CFR 211.113 and 21CFR 211.165) relating to the
importance of objectionable microorganisms. This is not the concern of
the compendial chapters. The controversy is worthy of discussion, but not
the topic of this review it will be discussed in length in the final of three
articles on the harmonization of the microbial limits tests to be published in
next months newsletter.

What follows is a tabular presentation of the existing Microbial Limits

Absence of Specified Microorganisms tests from the current USP and
Pharm Eur, as well as the draft harmonized document (the finalized
document is extremely close to this version, but not release to the industry).
It is provided as an aid to evaluation, and may assist in determining whether
revalidation of method suitability studies is needed. It should be noted that
this harmonization draft represents a true compromise by all parties, with
(at least in the authors opinion) significant changes from the current USP,
Pharm Eur and JP chapters.

Note: Due to its extreme length, Table 2 is provided here as a .pdf file from
the PMF Newsletter article

References

1 EP. 2006. 2.6.13 Microbiological Examination of Non-Sterile Products

(Test for Specified Micro-Organisms). Pharm Eur. 5.0:156-161

2 USP. 2003. <62> Microbiological Examination of Nonsterile Products:

Tests for Specified Microorganisms Pharm Forum. 29(5):1722-1733

3 USP. 2006. <61> Microbial Limits Tests USP 29:2503-2508